Catalog Number 1012453-12 |
Device Problems
Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/18/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal file number - (b)(4).
The device was not returned for evaluation.
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.
Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.
The nc trek rx coronary dilatation catheters, instruction for use states that if resistance is felt, determine the cause before proceeding.
Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.
The investigation determined the reported difficulty positioning the device appears to be related to circumstances of the procedure; however, the reported shaft separation appears to be related to user error.
There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
|
|
Manufacturer Narrative
|
(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
Excessive force.
The customer reported the device is not returning.
Investigation is not yet complete.
A follow up report will be submitted with all relevant information.
The other nc trek referenced is filed under a separate medwatch report.
|
|
Event Description
|
It was reported that during a left anterior descending coronary artery procedure, two 4.
0 x 12 mm nc trek dilatation catheters were attempted to be used in a kissing balloon technique.
Both dilatation catheters were inserted into a 6french guide catheter.
As the dilatation catheters were inserted, resistance was noted.
It was thought that the guide wires became tangled and the dilatation catheters had resistance advancing over the guide wires.
An attempt was made to force the dilatation catheters through the guide catheters, but the shafts separated.
Both separated nc trek catheters were easily removed.
There was no adverse patient effect or a clinically significant delay.
No additional information was provided.
|
|
Search Alerts/Recalls
|